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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING
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BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING Back to Search Results
Model Number 442022
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2022
Event Type  malfunction  
Event Description
It was reported that bd bactec¿ plus anaerobic/f culture vials (plastic) had a bottle with two labels with one overlapping the other.No patient impact was reported.The following information was provided by the initial reporter: according to the customer's report, there was a bottle with 2 labels, one overlapping the other.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd bactec¿ plus anaerobic/f culture vials (plastic) had a bottle with two labels with one overlapping the other.No patient impact was reported.The following information was provided by the initial reporter: according to the customer's report, there was a bottle with 2 labels, one overlapping the other.
 
Manufacturer Narrative
H6: investigation summary: a complaint history review was conducted and only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.Complaint is confirmed based on photo sent by the customer.An assessment was performed by the engineering department to determine if the weiler labeler had mechanical issues and/or breakdowns during the packaging process of aforementioned batch.Investigation revealed that preventive maintenance activities to the weiler labeler machine was completed on time as scheduled.Upon evaluation of breakdowns / incidents reports, there were no malfunctions related to overlapping labels.In the production reports, there were multiple issues on the weiler labeler related to jams, machine out of synchronization and broken roll.These types of issues are resolved during the labeling process.The machine was inspected and was working as expected.Product insert warnings and precautions sections states that prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depresses septum, or leakage.Vials showing evidence of contamination should not be used.Also prior to use, the user should examine the vial for evidence of damage or deterioration.Vials displaying turbidity, contamination, or discoloration (darkening) should not be used.No trend has been identified for the reported defect.No corrective actions required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.
 
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Brand Name
BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC)
Type of Device
SYSTEM, BLOOD CULTURING
Manufacturer (Section D)
BECTON DICKINSON CARIBE LTD.
vicks drive
lot no. 6
cayey PR
Manufacturer (Section G)
BECTON DICKINSON CARIBE LTD.
vicks drive
lot no. 6
cayey PR
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15636598
MDR Text Key307007320
Report Number2647876-2022-00220
Device Sequence Number1
Product Code MDB
UDI-Device Identifier00382904420222
UDI-Public00382904420222
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K141810
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2022
Device Model Number442022
Device Catalogue Number442022
Device Lot Number2041605
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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